MAUDE Adverse Event Report: CONMED UTICA LINVATEC H/C LIGHTWAVE ABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	IA-2379
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer, that the ia-2379, linvatec h/c lightwave ablator was being used during an arthroscopy procedure on (b)(6) 2023 when it was reported ¿it was "triggering" on its own even without pressing the button, and sometimes when activated it also didn't work, the device was changed twice, to see if the defect was in the equipment, but the error was repeated.We were informed that there was no harm or injury to the patient, did not fall fragments on the patient.Another product was used to replace it; however, they decided not to use it again.Surgery time was affected.¿.Further assessment questioning found that there was an approximate 20-30 minute delay.The procedure was completed and the current status of the patient was reported as ¿the patient is doing well, the doctor was able to carry out the complete procedure despite the defect.¿.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer, that the ia-2379, linvatec h/c lightwave ablator was being used during an arthroscopy procedure on (b)(6) 2023 when it was reported ¿it was "triggering" on its own even without pressing the button, and sometimes when activated it also didn't work, the device was changed twice, to see if the defect was in the equipment, but the error was repeated.We were informed that there was no harm or injury to the patient, did not fall fragments on the patient.Another product was used to replace it; however, they decided not to use it again.Surgery time was affected.¿.Further assessment questioning found that there was an approximate 20-30 minute delay.The procedure was completed and the current status of the patient was reported as ¿the patient is doing well, the doctor was able to carry out the complete procedure despite the defect.¿.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The console doesn¿t recognize the device and won¿t operate due to ¿replace probe error¿.The disposition is ¿inconclusive¿ because the device cannot be made to activate.A likely cause of this issue is due to tissue or fluid ingress into the button site affecting button depression.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the electrical shock hazards and safety considerations: a) this equipment is capable of producing a physiological effect and is for use only by licensed physicians trained in the use of this device.B) examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: LINVATEC H/C LIGHTWAVE ABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18325694
• Report Number: 1320894-2023-00268
• Device Sequence Number: 17880510
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• UDI-Public: (01)10845854040355(17)280603(10)202306051
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IA-2379
• Device Lot Number: 202306051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic